Masitinib in Patients With Primary Progressive Multiple Sclerosis (PPMS) or Relapse-free Secondary Progressive Multiple Sclerosis (SPMS)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01450488
• Date of registration: 06/10/2011
• Primary sponsor: AB Science
• Public title: Masitinib in Patients With Primary Progressive Multiple Sclerosis (PPMS) or Relapse-free Secondary Progressive Multiple Sclerosis (SPMS)
• Scientific title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Activity of Oral AB1010 Administered at 2 Dose Levels to Patients With Primary Progressive or Relapse-free Secondary Progressive Multiple Sclerosis
• Date of first enrolment: June 2005
• Target sample size: 35
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01450488
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients aged 18 to 60 years, from both sex, and suffering from multiple sclerosis
either primary progressive or secondary progressive without relapse within 2 years
before inclusion.

2. Patients with EDSS score in the range of 2 to 6.5, inclusive

3. EDSS progression = 1 point within 2 years before inclusion

Exclusion Criteria:

1. Disease other than MS responsible for clinical signs and/or MRI lesions

2. Secondary progressive MS with relapse in the 2 years before inclusion

3. Treatment with interferon or glatiramer acetate within four weeks prior to treatment
allocation

4. Treatment with oral or systemic corticosteroids or ACTH within four weeks prior to
treatment allocation.

5. Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes
zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: masitinib

Primary Outcome(s)

change in MSFC [Time Frame: 12 months]

Secondary Outcome(s)

Expanded Disability Status Scale (EDSS) [Time Frame: 12 months]

MFSC subcategories [Time Frame: 12 months]

MSFC subcategories [Time Frame: 12 months]

Secondary ID(s)

AB04011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors